Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
Applicant's election without traverse of Group I, claims 1, 4, 5 and 12-20 in the reply filed on 04/01/2026 is acknowledged. Applicant further elected SEQ ID No. 1089. Applicant did not elect a target region of SEQ ID No. 2 as required on page 5 of the O.A. mailed 10/03/2025. The response to the election requirement is considered non-responsive. In the interest of compact prosecution, a review of the Specification, in the table on page 138, describes SEQ ID No. 1089 as binding in the region of nucleobases 5605-5620 of SEQ ID No. 2 and therefore the binding region 5567-5642 will be examined.
After further consideration, claims 2, 6, 7 and 8 will be rejoined and examined.
Status of the Application
Claims 1-20 are pending. Claims 1, 2, 4-8 and 12-20 are currently under examination. Claims 3, 9, 10 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Antisense sequences comprising 8-12 contiguous nucleotides of SEQ ID No. 1089 and antisense sequences targeting bases 5567-5642 of SEQ ID No. 2. for use in methods of treating an individual having or at risk of a liver disease are free of the prior art.
Specification
The use of the terms ATCC, GENBANK and LIPOFECTAMINE, which are trade names or marks used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore each term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4-6, 12-14 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hinkle et al. (US Patent Application No. 20180201936).
Regarding claims 1, 2, 4-6, 12-14 and 16, Hinkle et al. teach a method of treating a subject with nonalcoholic fatty liver disease (NAFLD) or liver steatosis comprising administering an antisense oligonucleotide targeted to PNPLA3 and wherein the subject has an I148M mutation that is homozygous (see 0003-0005, 0007 and 0047).
Thus Hinkle et al. anticipates the instant claims.
Claim(s) 1, 2, 4-6, 12, 13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fitzgerald et al. (US Patent No. 10,231,988).
Regarding claims 1, 2, 4-6, 12, 13 and 15, Fitzgerald et al. teach a method of treating a subject with nonalcoholic fatty liver disease (NAFLD) or liver steatosis comprising administering an siRNA targeted to PNPLA3 and wherein the subject has an I148M mutation that is homozygous (see col. 1, 2 and 13).
Thus Fitzgerald et al. anticipates the instant claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 7, 8, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hinkle et al. (US Patent Application No. 20180201936) and Carpino et al. ("Macrophage activation in pediatric nonalcoholic fatty liver disease (NAFLD) correlates with hepatic progenitor cell response via Wnt3a pathway." PloS one 11.6 (2016)).
Regarding claims 7 and 8, Hinkle et al. teach a method of treating a subject with nonalcoholic fatty liver disease (NAFLD) or liver steatosis comprising administering an antisense oligonucleotide targeted to PNPLA3 but does not teach reducing liver macrophage levels. Carpino et al. teach the activation of liver macrophages is a central event in the progression of NAFLD (see abstract). Carpino et al. teach macrophage infiltration and activation seem to have a key role in the progression toward NASH in pNAFLD (see page 16) and teach measuring macrophage using immunohistochemistry (see page 3). It would have been obvious to one of skill in the art that reducing liver inflammation using an antisense oligonucleotide targeted to PNPLA3 would reduce liver macrophage levels and one of skill would use the methods of Hinkle et al. to reduce the level to 20% or more in efforts to treat liver inflammation given macrophage infiltration and activation seem to have a key role in the progression toward NASH in pNAFLD.
Regarding claims 17-20, Hinkle et al. teach a method of treating a subject with nonalcoholic fatty liver disease (NAFLD) or liver steatosis comprising administering an antisense oligonucleotide targeted to PNPLA3 and wherein the subject has an I148M mutation that is homozygous (see 0003-0005, 0007 and 0047). Hinkle et al. teach the antisense oligonucleotide can be modified (0131). Hinkle et al. does not specifically teach the antisense targeted to PNPLA3 comprises a modified oligonucleotide have at least 8-12 contiguous nucleobases of SEQ ID No. 1089 or targeting bases 5567-5642 of SEQ ID No. 2.
Hinkle et al. teach the human PNPLA3, “patatin-like phospholipase domain containing 3” gene, (human: NCBI refseqID NM_025225; NCBI GeneID: 80339) and methods of designing antisense oligonucleotide targeted to the gene. Hinkle et al. teach antisense oligonucleotides can be made by starting at position 1 by gene walking wherein antisense can be made every 11 bases along the entire mRNA. Hinkle et al. teach testing the efficacy of the antisense oligonucleotide by Predicted efficacy was used to allow for the substitution of a neighboring, predicted-to-be-more-potent ASO design where the neighboring ASO was 1 base either toward the 5′ or 3′ end of the mRNA. Low complexity ASO designs were removed by filtering with a Shannon entropy index greater than 1.35 to find optimal antisense oligonucleotides to use in methods of treatment (see 0451).
It would have been obvious to use the known methods of Hinkle et al. to make the claimed antisense oligonucleotides of 8-12 contiguous nucleotides targeted to the PNPLA3 gene in efforts to find an optimal antisense for treatment of a subject having or at risk of a liver disease.
Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 20 is drawn to an oligonucleotide 8 to 80 nucleotides comprising at least 8 contiguous nucleotides 100% complementary to nucleobases 5567-5642 of SEQ ID Nos. 2 and wherein the oligonucleotide is at least 85%, 90% or 95% complementary to SEQ ID No. 2. This limitation is indefinite because it unclear how an oligonucleotide 8 nucleotides in length and 100% complementary to nucleobases 5567-5642 of SEQ ID Nos. 2 can also be 85%, 90% or 95% complementary to SEQ ID No. 2. The 8 nucleotide oligonucleotide can only be 100% complementary to SEQ ID No. 2.
Thus the claim fails to particularly point out and distinctly claim the subject matter.
Enablement
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4-8 and 12-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification,
while being enabling for methods of treating an individual having or at risk of having a liver disease comprising administering an antisense having a length of 16 nucleotides targeted to PNPLA3 and methods of using for the treatment of liver disease such as inflammation, fibrosis and liver steatosis,
does not reasonably provide enablement for methods of treating an individual having or at risk of having a liver disease comprising administering any compound targeted to PNPLA3 or using any antisense sense having 8-12 contiguous nucleotides of any of SEQ ID No. 1089 or targeting bases 5567-5642 of SEQ ID No. 2,
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The following factors have been considered in the analysis of enablement: (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims and the nature of the invention:
The broadest reasonable interpretation of “a compound” is any molecule such as nucleic acids, small molecules, chemical compounds, aptamers or gene editing using CRISPR, for example. Therefore the methods are interpreted as treating an individual having or at risk of any liver disease using any type of compound to target PNPLA3. The method is also interpreted such that any antisense oligonucleotide comprising at least 8-12 nucleotides of the claimed SEQ ID No. or targeted to a region of PNPLA3 could be used for the methods of treatment. A skilled artisan would not know how to use the method with a reasonable expectation of success based solely on what is disclosed in the specification.
Whether the specification would have been enabling as of the filing date involves consideration of the nature of the invention, the state of the prior art, and the level of skill in the art. The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b). The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification.
The state of the prior art:
The prior art is replete with methods of inhibiting PNPLA3 expression using antisense and siRNA inhibitors of gene expression (see Hinkle et al. and Fitzgerald et al. cited above). A review of the prior art does not provide methods of using any type of compound for targeting PNPLA3 or using any antisense oligonucleotide comprising 8-12 nucleotides targeted to PNPLA that reduces expression for treatment of a liver disease.
The level of one of ordinary skill:
While the level of one of ordinary skill practicing said invention would be high, the level of predictability is considered variable as evident in the prior art discussed above and is not considered to provide sufficient enablement to practice the claimed invention.
Because the state of the prior art does not provide evidence of the degree of predictability that methods for treating any liver disease in a subject can occur by administering to the subject any compound targeted to PNPLA3, one of ordinary skill in the art would look for guidance or direction in the instant specification.
The level of predictability in the art:
“The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability.” (MPEP 2164.03).
The amount of direction provided by the inventor:
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. >See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004).
The existence of working examples:
The working embodiment in the instant application describes using an antisense oligonucleotide, 16 nucleotides in length, targeted to PNPLA3 for treatment of liver disease such as inflammation, fibrosis and liver steatosis. The working embodiments do not describe using any type of compound targeted to PNPLA3 for treatment of any liver disease in a subject or using any antisense oligonucleotide 8-12 nucleotides in length that binds to PNPLA3.
The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004).
While the MPEP 2164.02 states the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970), the lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
The prior art is undeveloped for the inhibition of PNPLA3 using any type of compound or antisense oligonucleotides at least 8-12 nucleotides in length in a subject and treatment of any liver disease. The specification does not provide sufficient guidance and without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
Written Description
Claims 1, 2, 4-8, and 12-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966; Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial Structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed structure, and v. Correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art.
Moreover, the written description requirement for a genus may be satisfied through sufficient description of a representative number of species by “…disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between functional and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” Thus when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The claims are drawn to a vast genus of compounds targeted to PNPLA3 and to a vast number of antisense oligonucleotides having 8-12 consecutive nucleotides of SEQ ID No. 1089 or binding to nucleobases 5567-5642 of SEQ ID No. 2.
In determining whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described to represent the entire genus. With respect to the genus of compounds, the specification describes only using antisense oligonucleotides targeted to PPLA3. The instant specification describes antisense targeted to PNPLA3 having 16 nucleotides in length that when administered to mice, resulted in treatment of liver diseases such as inflammation, fibrosis and liver steatosis (see Table 76 and Examples 13-16). Antisense oligonucleotides are not presentative of the genus of compounds claimed and antisense oligonucleotides of 16 nucleotides is not repetitive of the vast number sized of antisense oligonucleotides claimed.
Next it is determined whether a representative number of species have been sufficiently described by other relevant identifying characteristics (i.e. other than nucleotide sequence), specific features and functional attributes that would distinguish different members of the claimed genera. In the instant case, the only functional characteristics are inhibition of PNPLA3 expression using antisense oligonucleotides 16 nucleotides in length. Such functional limitations cannot be the identifying characteristics for the vast number of compounds and differently sized antisense oligonucleotides. The specification does not describe using any type of compound or using antisense oligonucleotide at least 8-12 nucleotides in length of the claimed sequence or binding to nucleobases 5567-5642 of SEQ ID No. 2. A review of the specification shows that it provides no description or guidance that would allow one of skill to distinguish the functional species of the recited structural genus from the non-functional members without empirical determination.
Since the disclosure and the prior art fail to describe the common attributes and characteristics concisely identifying members of the proposed genus, and because the claimed genus is highly variant a vast number of different compounds and differently sized antisense oligonucleotides, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus claimed.
"A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus" (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) (emphasis added).
Further, “Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
Thus the specification and claims lack written description because it is clear that Applicant did not have possession of every compound targeted to PNPLA3 and every sized antisense oligonucleotide claimed. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521,222 USPQ 369,372-372 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the entire scope of the claimed invention.
Closest prior art
The closest prior art is Metsky et al. (US Patent No. 11,332,783) who teach a nucleic acid sequence 75 nucleotides in length comprising at least 8 contiguous nucleotides identical to SEQ ID No. 1089. Metsky et al. describes this sequence as an oligonucleotide probe and not an antisense targeted to PNPLA3 and further it would not be obvious to use this to target PNPLA3.
Patent No. 11332783
GENERAL INFORMATION
APPLICANT: Metsky, Hayden
SEQ ID NO 316182
LENGTH: 75
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic
Query Match 93.8%; Score 15; Length 75;
Best Local Similarity 100.0%;
Matches 15; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
SEQ 1089 2 TTTATTCAATGTGGC 16
SEQ 316182 41 TTTATTCAATGTGGC 55
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Chong at (571)272-3111. The examiner can normally be reached Monday thru Friday between M-F 8:00am-4:30pm.
If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY CHONG/
Primary Examiner Art Unit 1636
Prosecution Insights